Study Stopped
A program evaluation identified that the safety profile and pharmacokinetic (PK) characteristics of the formulation used in all oprozomib studies required further optimization and thus enrollment in 2011-001 was halted.
Open-label Study of the Safety and Activity of Oprozomib in Patients With Hematologic Malignancies
Phase 1b/2, Multicenter, Open-label Study of the Safety and Activity of Oprozomib in Patients With Hematologic Malignancies
1 other identifier
interventional
210
1 country
19
Brief Summary
The purpose of this study is to determine the maximum tolerated dose (MTD), activity, and safety of oprozomib in patients with hematologic malignancies.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 multiple-myeloma
Started Oct 2011
Longer than P75 for phase_1 multiple-myeloma
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 11, 2011
CompletedFirst Posted
Study publicly available on registry
August 15, 2011
CompletedStudy Start
First participant enrolled
October 15, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 8, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 12, 2019
CompletedNovember 8, 2022
November 1, 2022
4.8 years
August 11, 2011
November 4, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Determine the MTD (Phase 1) and ORR (Phase 2).
Phase 1- Determine Maximum Tolerated Dose (MTD) with 3 + 3 Dose Escalation Cohorts in patients hematologic malignancies. Phase 2- The Phase 2 portion of this trial will enroll patients with Multiple Myeloma (MM) and Waldenstrom Macroglobulinemia (WM) into separate arms to assess activity of oprozomib in these patient groups. The purpose of the Phase 2 portion of the study is to estimate the best ORR (for each group separately).
6 weeks to 18 months
Secondary Outcomes (17)
Evaluate the duration of response (DOR)
64 months
Estimate the clinical benefit response (CBR)
64 months
Estimate the major response for Waldenström macroglobulinemia (WM)
64 months
Evaluate progression-free survival (PFS) for multiple myeloma (MM) subjects
64 months
Evaluate the PFS for Waldenström macroglobulinemia (WM) subjects
64 months
- +12 more secondary outcomes
Study Arms (2)
QDx2 Dosing Schedule
EXPERIMENTALQDx2 is defined as patients receiving Oprozomib Tablets once daily on Days 1, 2, 8, and 9 of the 14-day cycle. The schedule will be evaluated in Phase 1 for MTD in patients with hematologic malignancies, and will also be evaluated in Phase 2 for ORR in patients with MM and WM.
QDx5 Dosing Schedule
EXPERIMENTALQDx5 is defined as patients receiving Oprozomib Tablets once daily on Days 1 to 5 of the 14-day cycle. The schedule will be evaluated in Phase 1 for MTD in patients with hematologic malignancies, and will also be evaluated in Phase 2 for ORR in patients with MM and WM.
Interventions
Patients enrolled will receive Oprozomib Tablets once daily either on Days 1-5 (QDx5 schedule) or on Days 1, 2, 8, and 9 (QDx2 weekly schedule) of the 14-day treatment cycle.
Eligibility Criteria
You may qualify if:
- Phase 1b
- Histologically confirmed diagnosis of a hematologic malignancy, excluding patients with acute leukemia or MDS.
- Relapsed after standard therapy for their malignancy and considered to be an appropriate candidate for a Phase 1 clinical study by their treating physician.
- Phase 2
- Multiple myeloma with measurable disease
- Waldenström macroglobulinemia with symptomatic relapse
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2.
- Ethical/Other
- Patients must sign a written informed consent form in accordance with federal, local, and institutional guidelines.
- Female patients of childbearing potential must have a negative serum or urine pregnancy test and agree to use effective contraception. Male patients must use an effective barrier method of contraception.
You may not qualify if:
- Chemotherapy with approved or investigational anticancer therapeutics, including steroid therapy intended to treat underlying malignancy, within 3 weeks prior to first dose or 6 weeks for antibody therapy.
- Radiation therapy within 3 weeks prior to first dose. Radioimmunotherapy within 8 weeks prior to first dose. Localized radiation therapy within 1 week prior to first dose.
- Immunotherapy within 3 weeks prior to first dose (except for antibody therapy, where 6 weeks is required).
- Prior stem cell transplant (SCT) therapy (autologous SCT within the prior 8 weeks; allogeneic SCT within the prior 16 weeks). Patients with prior allogeneic SCT should not have evidence of moderate-to-severe graft-vs-host disease (GvHD; as defined in Filipovich 2005).
- Evidence of central nervous system (CNS) lymphoma.
- Prior treatment with carfilzomib unless in the phase 2.
- Major surgery within 3 weeks prior to first dose.
- Symptomatic Congestive heart failure, ischemia, conduction abnormalities, or myocardial infarction within 6 months.
- Acute active infection requiring systemic antibiotics, antivirals, or antifungals.
- Known or suspected human immunodeficiency virus (HIV) infection or patients who are HIV seropositive.
- Active hepatitis A, B, or C infection.
- Significant neuropathy (Grade 3, Grade 4, or Grade 2 with pain) at the time of the first dose.
- Patients with pleural effusions requiring routine thoracentesis or ascites requiring routine paracentesis.
- History of previous clinically significant GI bleed in the last 6 months prior to first dose.
- Female patients who are pregnant or lactating.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (19)
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States
Pacific Cancer Care
Salinas, California, United States
Colorado Blood Cancer Institute
Denver, Colorado, United States
Mayo Clinic
Jacksonville, Florida, United States
Winship Cancer Institute, Emory University
Atlanta, Georgia, United States
Rush University Medical Center
Chicago, Illinois, United States
University of Chicago Medical Center
Chicago, Illinois, United States
University of Maryland, Greenebaum Cancer Center
Baltimore, Maryland, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Mass General Hospital
Boston, Massachusetts, United States
Virginia Piper Cancer Institute
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
Washington University School of Medicine Division of Oncology
St Louis, Missouri, United States
John Theurer Cancer Center at Hackensack University
Hackensack, New Jersey, United States
Hematology Oncology of Northern New Jersey
Morristown, New Jersey, United States
New York Oncology Hematology
Albany, New York, United States
Mount Sinai Medical Center
New York, New York, United States
Sarah Cannon Research Institute / Tennessee Oncology, PLLC
Nashville, Tennessee, United States
Columbia Basin Hematology and Oncology
Kennewick, Washington, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
MD
Amgen
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 11, 2011
First Posted
August 15, 2011
Study Start
October 15, 2011
Primary Completion
August 8, 2016
Study Completion
August 12, 2019
Last Updated
November 8, 2022
Record last verified: 2022-11